on March 29, 2007
Published online before print March 29, 2007, doi: 10.1161/STROKEAHA.106.477711
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Submitted on November 10, 2006
From the Lenox Hill Hospital (A.B.), New York, NY; University of Heidelberg Medical Center (M.H.), Heidelberg, Germany; Robert Janker Klinik and Alfried Krupp Krankenhaus (H.H.), Bonn, Germany; National Taiwan University Hospital (H.M.L.), Taipei, Taiwan; Taipei Veterans General Hospital and National Yang Ming University (M.T.), Taipei, Taiwan; National Institute of Neurosurgery (I.S.), Budapest, Hungary; Klinikum der Universität Freiburg (A.B.), Freiburg, Germany; Kreiskrankenhaus Siegen (J.R.), Siegen, Germany; Prince of Wales Hospital (S.Y.), Hong Kong; Universitätsklinikum Essen (M.F.), Essen, Germany; Queen Mary Hospital (M.L.), Hong Kong; Singapore General Hospital (W.L.), Singapore; and Penumbra Inc (S.P.S.), San Leandro, Calif. * To whom correspondence should be addressed. E-mail: ssit{at}penumbrainc.com.
Background and Purpose--The purpose of this study was to assess the safety and performance of the Wingspan stent system and Gateway percutaneous transluminal angioplasty balloon catheter in the treatment of high-grade, intracranial atherosclerotic lesions in patients who had failed medical therapy. Methods--In this prospective, multicenter, single-arm study, medically refractory patients with a modified Rankin score Results--Among the 45 patients enrolled, the degree of stenosis was reduced from a baseline of 74.9±9.8% to 31.9±13.6% after stenting and 28±23.2% at the 6-month follow-up. The 30-day composite ipsilateral stroke/death rate was 4.5% (2/44); at the 6-month follow-up, the ipsilateral stroke/death rate was 7.0%, the rate for all strokes was 9.7%, and all-cause mortality was 2.3%. Physician-reported follow-up in 43 patients (average of 13 months) conducted outside the study protocol (not adjudicated by the clinical event committee) reported 1 additional ipsilateral stroke. Conclusions--In medically refractory patients with high-grade intracranial atherosclerotic stenoses, a new treatment paradigm involving predilation with an undersized Gateway percutaneous transluminal angioplasty balloon catheter and placement of a self-expanding Wingspan stent system appears to be safe, may facilitate remodeling, and may contribute to favorable angiographic outcomes.
Accepted on November 23, 2006
A Novel, Self-Expanding, Nitinol Stent in Medically Refractory Intracranial Atherosclerotic Stenoses. The Wingspan Study
Arani Bose MD;
3 and recurrent symptoms attributable to angiographically demonstrated intracranial stenosis 
50% in a vessel 2.5 to 4.5 mm in diameter were enrolled. Intracranial lesions were predilated with an undersized Gateway balloon catheter to 80% of the native vessel diameter, followed by deployment of the self-expanding Wingspan stent to facilitate further remodeling of the atherosclerotic plaque and to maintain vessel patency. Neurologic examinations and angiograms were performed at 6 months after the procedure.
Key words: atherosclerosis • medical therapy • nitinol stent • stenosis • stroke
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